RU2006136267A - TREATMENT OF SEVERE HOSPITAL PNEUMONIA BY INTRODUCING TISSUE FACTOR (TFPI) INHIBITOR - Google Patents

TREATMENT OF SEVERE HOSPITAL PNEUMONIA BY INTRODUCING TISSUE FACTOR (TFPI) INHIBITOR Download PDF

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RU2006136267A
RU2006136267A RU2006136267/14A RU2006136267A RU2006136267A RU 2006136267 A RU2006136267 A RU 2006136267A RU 2006136267/14 A RU2006136267/14 A RU 2006136267/14A RU 2006136267 A RU2006136267 A RU 2006136267A RU 2006136267 A RU2006136267 A RU 2006136267A
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tfpi
analog
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glycosylated
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Эбла КРИЗИ (US)
Эбла КРИЗИ
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Чирон Корпорейшн (Us)
Чирон Корпорейшн
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/16—Central respiratory analeptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (42)

1. Способ лечения или профилактики тяжелой пневмонии, включающий введение ингибитора пути тканевого фактора (TFPI) или аналога TFPI пациенту, у которого наблюдается или есть риск развития тяжелой пневмонии, путем непрерывного внутривенного вливания со скоростью дозирования, эквивалентной введению стандартного ala-TFPI со скоростью дозирования менее чем около 1,0 мг/кг/ч, и пациент не получает антикоагулянт в течение 24 ч от введения TFPI или аналога TFPI.1. A method of treating or preventing severe pneumonia, comprising administering a tissue factor pathway inhibitor (TFPI) or TFPI analogue to a patient who is or is at risk of developing severe pneumonia, by continuous intravenous infusion at a dosage rate equivalent to standard ala-TFPI at a dosage rate less than about 1.0 mg / kg / h, and the patient does not receive an anticoagulant within 24 hours from the administration of TFPI or a TFPI analogue. 2. Способ по п.1, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.2. The method according to claim 1, wherein said TFPI analog is non-glycosylated ala-TFPI. 3. Способ по п.1, в котором указанный пациент имеет доказанную инфекцию.3. The method according to claim 1, wherein said patient has a proven infection. 4. Способ по п.1, в котором указанный TFPI или аналог TFPI вводят непрерывным внутривенным вливанием со скоростью дозирования, эквивалентной введению стандартного ala-TFPI со скоростью дозирования менее чем около 0,80 мг/кг/ч.4. The method according to claim 1, wherein said TFPI or TFPI analog is administered by continuous intravenous infusion at a dosage rate equivalent to the administration of standard ala-TFPI with a dosage rate of less than about 0.80 mg / kg / h. 5. Способ по п.4, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,025 до около 0,10 мг/кг/ч и в котором указанный TFPI или аналог TFPI вводят, по меньшей мере, в течение 72 ч.5. The method according to claim 4, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.025 to about 0.10 mg / kg / h and wherein said TFPI or TFPI analog is administered in at least within 72 hours 6. Способ по п.5, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,010 до около 0,10 мг/кг/ч.6. The method according to claim 5, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.010 to about 0.10 mg / kg / h. 7. Способ по п.6, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.7. The method of claim 6, wherein said TFPI analog is non-glycosylated ala-TFPI. 8. Способ по п.6, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,020 до около 0,08 мг/кг/ч/.8. The method of claim 6, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.020 to about 0.08 mg / kg / h /. 9. Способ по п.8, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.9. The method of claim 8, wherein said TFPI analog is non-glycosylated ala-TFPI. 10. Способ по п.1, в котором указанный TFPI или указанный аналог TFPI вводят в течение, по меньшей мере, 96 ч.10. The method according to claim 1, wherein said TFPI or said TFPI analogue is administered for at least 96 hours 11. Способ по п.10, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.11. The method of claim 10, wherein said TFPI analog is non-glycosylated ala-TFPI. 12. Способ по п.10, в котором указанный TFPI или аналог TFPI вводят непрерывным внутривенным вливанием для получения общей дозы, эквивалентной введению стандартного ala-TFPI в общей дозе от около 0,025 до около 2,5 мг/кг.12. The method of claim 10, wherein said TFPI or TFPI analog is administered by continuous intravenous infusion to obtain a total dose equivalent to the administration of standard ala-TFPI in a total dose of from about 0.025 to about 2.5 mg / kg. 13. Способ по п.12, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.13. The method of claim 12, wherein said TFPI analog is non-glycosylated ala-TFPI. 14. Способ по п.10, в котором указанный TFPI или аналог TFPI вводят непрерывным внутривенным вливанием со скоростью дозирования, эквивалентной введению стандартного ala-TFPI со скоростью дозирования от около 0,02 до около 0,09 мг/кг/ч.14. The method of claim 10, wherein said TFPI or TFPI analog is administered by continuous intravenous infusion at a dosage rate equivalent to the administration of standard ala-TFPI at a dosage rate of from about 0.02 to about 0.09 mg / kg / h. 15. Способ по п.14, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.15. The method of claim 14, wherein said TFPI analog is non-glycosylated ala-TFPI. 16. Способ по п.1, в котором указанный TFPI или аналог TFPI вводят непрерывным внутривенным вливанием для получения суточной дозы, эквивалентной введению стандартного ala-TFPI в суточной дозе от около 0,06 до около 4 мг/кг.16. The method according to claim 1, wherein said TFPI or TFPI analog is administered by continuous intravenous infusion to obtain a daily dose equivalent to the administration of standard ala-TFPI in a daily dose of from about 0.06 to about 4 mg / kg. 17. Способ по п.16, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.17. The method of claim 16, wherein said TFPI analog is non-glycosylated ala-TFPI. 18. Способ по п.1, в котором указанный аналог TFPI содержит первый домен Кунитца, состоящий из аминокислот 19-89 последовательности SEQ ID NO:1.18. The method according to claim 1, wherein said TFPI analogue contains a first Kunitz domain consisting of amino acids 19-89 of the sequence SEQ ID NO: 1. 19. Способ по п.18, в котором указанный аналог TFPI дополнительно содержит второй домен Кунитца, состоящий из аминокислот 90-160 последовательности SEQ ID NO:1.19. The method of claim 18, wherein said TFPI analog further comprises a second Kunitz domain consisting of amino acids 90-160 of the sequence SEQ ID NO: 1. 20. Способ по п.1, в котором указанный аналог TFPI содержит аминокислоты 1-160 последовательности SEQ ID NO:1.20. The method according to claim 1, wherein said TFPI analogue contains amino acids 1-160 of the sequence SEQ ID NO: 1. 21. Способ по п.1, в котором указанный аналог TFPI содержит второй домен Кунитца, состоящий из аминокислот 90-160 последовательности SEQ ID NO:1.21. The method according to claim 1, wherein said TFPI analogue contains a second Kunitz domain consisting of amino acids 90-160 of the sequence SEQ ID NO: 1. 22. Способ по п.21, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.22. The method of claim 21, wherein said TFPI analog is non-glycosylated ala-TFPI. 23. Способ по п.1, в котором указанный TFPI или аналог TFPI получают из лиофилизированной композиции, содержащей TFPI или аналог TFPI.23. The method according to claim 1, wherein said TFPI or TFPI analog is obtained from a lyophilized composition containing TFPI or TFPI analog. 24. Способ по п.23, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.24. The method of claim 23, wherein said TFPI analog is non-glycosylated ala-TFPI. 25. Способ по п.1, в котором указанный TFPI или аналог TFPI вводят в виде состава, содержащего аргинин.25. The method according to claim 1, wherein said TFPI or TFPI analogue is administered as a composition containing arginine. 26. Способ по п.25, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.26. The method of claim 25, wherein said TFPI analog is non-glycosylated ala-TFPI. 27. Способ по п.1, в котором указанный TFPI или аналог TFPI вводят в виде состава, содержащего цитрат.27. The method according to claim 1, wherein said TFPI or TFPI analog is administered as a composition containing citrate. 28. Способ по п.27, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.28. The method of claim 27, wherein said TFPI analog is non-glycosylated ala-TFPI. 29. Способ по п.1, в котором указанный TFPI или аналог TFPI имеет концентрацию около 0,15 мг/мл в составе, включающем около 300 мМ гидрохлорида аргинина и около 20 мМ цитрата натрия, и имеет рН около 5,5.29. The method according to claim 1, wherein said TFPI or TFPI analog has a concentration of about 0.15 mg / ml in a composition comprising about 300 mM arginine hydrochloride and about 20 mM sodium citrate, and has a pH of about 5.5. 30. Способ по п.29, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.30. The method according to clause 29, wherein said TFPI analog is non-glycosylated ala-TFPI. 31. Способ по п.1, дополнительно включающий введение одновременно или в течение 24 ч от введения указанного TFPI или аналога TFPI дополнительного агента, выбираемого из группы, включающей антибиотик, антитело, антагонист эндотоксина, аналог тканевого фактора с антикоагулирующей активностью, иммуностимулятор, блокатор клеточной адгезии, гепарин, белок BPI (бактерицидный белок, увеличивающий проницаемость), антагонист IL-1, пафазу (ингибитор фермента PAF (фактора активации тромбоцитов)), ингибитор TNF (фактора некроза опухоли), ингибитор IL-6 и ингибитор комплемента.31. The method according to claim 1, further comprising administering simultaneously or within 24 hours from the administration of said TFPI or TFPI analogue of an additional agent selected from the group consisting of an antibiotic, antibody, endotoxin antagonist, tissue factor analogue with anticoagulating activity, immunostimulant, cell blocker adhesion, heparin, BPI protein (bactericidal permeability enhancing protein), IL-1 antagonist, papase (inhibitor of the PAF enzyme (platelet activating factor)), TNF inhibitor (tumor necrosis factor), IL-6 inhibitor and inhibitor complement. 32. Способ по п.31, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.32. The method of claim 31, wherein said TFPI analog is non-glycosylated ala-TFPI. 33. Способ по п.31, в котором указанный дополнительный агент представляет собой антитело, причем указанное антитело специфично связывается с антигеном, выбираемым из группы, включающей TNF, IL-6 и M-CSF.33. The method according to p, in which the specified additional agent is an antibody, and the specified antibody specifically binds to an antigen selected from the group comprising TNF, IL-6 and M-CSF. 34. Способ по п.33, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.34. The method of claim 33, wherein said TFPI analog is non-glycosylated ala-TFPI. 35. Способ лечения тяжелой пневмонии, включающий введение пациенту (i) TFPI или аналога TFPI и (ii) дополнительного агента, выбираемого из группы, включающей антибиотик, моноклональное антитело, ингибитор цитокина и ингибитор комплемента.35. A method of treating severe pneumonia, comprising administering to a patient (i) TFPI or a TFPI analogue and (ii) an additional agent selected from the group consisting of an antibiotic, monoclonal antibody, a cytokine inhibitor, and a complement inhibitor. 36. Способ по п.35, в котором указанный аналог TFPI представляет собой негликозилированный ala-TFPI.36. The method of claim 35, wherein said TFPI analog is non-glycosylated ala-TFPI. 37. Способ по п.35, в котором у пациента имеется доказанная инфекция.37. The method according to clause 35, in which the patient has a proven infection. 38. Способ по п.35, в котором указанный TFPI или аналог TFPI вводят непрерывным внутривенным вливанием со скоростью дозирования, эквивалентной введению стандартного ala-TFPI со скоростью дозирования менее чем около 1,0 мг/кг/ч.38. The method of claim 35, wherein said TFPI or TFPI analog is administered by continuous intravenous infusion at a dosage rate equivalent to the administration of standard ala-TFPI at a dosage rate of less than about 1.0 mg / kg / h. 39. Способ по п.38, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,001 до около 0,090 мг/кг/ч.39. The method of claim 38, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.001 to about 0.090 mg / kg / h. 40. Способ по п.39, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,002 до около 0,050 мг/кг/ч.40. The method of claim 39, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.002 to about 0.050 mg / kg / h. 41. Способ по п.40, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,002 до около 0,010 мг/кг/ч.41. The method of claim 40, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.002 to about 0.010 mg / kg / h. 42. Способ по п.41, в котором указанная скорость дозирования эквивалентна введению стандартного ala-TFPI со скоростью дозирования от около 0,0025 до около 0,075 мг/кг/ч.42. The method according to paragraph 41, wherein said dosing rate is equivalent to administering standard ala-TFPI with a dosing rate of from about 0.0025 to about 0.075 mg / kg / h.
RU2006136267/14A 2004-03-17 2005-03-17 TREATMENT OF SEVERE HOSPITAL PNEUMONIA BY INTRODUCING TISSUE FACTOR (TFPI) INHIBITOR RU2006136267A (en)

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EP1729791A2 (en) 2006-12-13
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MXPA06010587A (en) 2007-03-29
CN101426520A (en) 2009-05-06
CA2560103A1 (en) 2005-11-24
US20080286279A1 (en) 2008-11-20
AU2005244249A1 (en) 2005-11-24
JP2007532486A (en) 2007-11-15

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